Search Results
Found 2 results
510(k) Data Aggregation
(134 days)
Huge Dental Material Co., Ltd.
PMMA BLOCK particularly suitable for making removable or temporary dental structures such as crowns and bridges using milling technology using CAD/CAM.
Indications for Use:
- Temporary anterior and posterior crowns;
- Temporary anterior and posterior bridges;
- Implant surgical guide;
- Removable structures for dentures;
- Removable structures for therapeutic restorations (night guards, bite splints or occlusal splints).
PMMA BLOCK is a circular solid (disc) or rectangular solid (block) of PMMA with or without post attachment for use in a CAD/CAM milling machine for production of provisional restorative prostheses such as dental crowns and bridges and removable dental structures. These blocks are available in a variety of shapes for different milling systems and are also available in variety of dental shades.
PMMA BLOCK are made with the same material (Hot cured PMMA) that is used for the manufacture of the HUGE Synthetic Polymer Teeth (K101029) and HUGE PMMA Block(K141421). These polymer discs or blocks are especially suited for creating dental structures by means of milling CAD/CAM techniques commonly used in the dental laboratories and in dental practice. The elaboration is designed by a professional, a dental technician or a dentist. This guarantees their correct use, since it is an intermediate product in order to manufacture a custom-made product.
The provided text is a 510(k) summary for the PMMA Block, a dental material. It outlines the device's characteristics and compares it to predicate devices to establish substantial equivalence.
However, the document does not contain any information about a study proving the device meets acceptance criteria related to AI or machine learning performance. The "acceptance criteria" discussed in the document pertain to the physical and chemical properties of the PMMA Block and its compliance with ISO standards for dental materials.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria for AI performance and reported device performance.
- Sample sizes, data provenance, number of experts for ground truth, adjudication methods for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- Type of ground truth used related to AI.
- Training set sample size or how ground truth for training was established.
The document focuses on the material's properties, chemical composition, and manufacturing process, asserting substantial equivalence to existing dental materials, not on the performance of an AI-powered device.
Summary of relevant information from the document (not directly answering the AI-related questions):
- Device: PMMA Block (dental polymer blanks)
- Purpose: For making removable or temporary dental structures (crowns, bridges, surgical guides, dentures, night guards/bite splints) using CAD/CAM milling.
- Study Type: This is a 510(k) premarket notification based on substantial equivalence to predicate devices, not a clinical performance study of a novel AI or medical imaging device.
- "Acceptance Criteria" presented: Primarily physical and chemical properties of the material, tested against ISO standards (ISO 10477, ISO 20795-1, ISO 22112).
- Flexural strength: The new device must meet $\ge$ 50 MPa (ISO 10477) and $\ge$ 65 MPa (ISO 20795-1).
- Water absorption: The new device must meet $\le$ 0.040 mg/mm³ (ISO 10477) and $\le$ 0.032 mg/mm³ (ISO 20795-1).
- Water solubility: The new device must meet $\le$ 0.0075 mg/mm³ (ISO 10477) and $\le$ 0.0016 mg/mm³ (ISO 20795-1).
- Residual monomer content: The new device must meet $\le$ 2.2% (ISO 20795-1).
- Dimensional stability: The new device must meet within ± 2% of original mesio-distal dimension (ISO 22112).
- Reported Device Performance (from Table 4):
- Flexural strength: $\ge$ 50 MPa and $\ge$ 65 MPa (meeting the criteria).
- Water absorption: $\le$ 0.040 mg/mm³ and $\le$ 0.032 mg/mm³ (meeting the criteria).
- Water solubility: $\le$ 0.0075 mg/mm³ and $\le$ 0.0016 mg/mm³ (meeting the criteria).
- Residual monomer content: $\le$ 2.2% (meeting the criteria).
- Dimensional stability: 0.29% (meeting the criteria of ± 2%).
- Biocompatibility: Tests were performed according to ISO 10993 standards (Systemic Toxicity, Irritation, Sensitization, Cytotoxicity, In Vitro Mammalian Cell TK Gene Mutation Test, In Vitro mammalian chromosome aberration test, and Bacterial reverse mutation study). The document states the device is "Non cytotoxic."
- Clinical Performance Data: "Not applicable. Clinical performance testing has not been performed for the subject device." (Section 10).
Ask a specific question about this device
(125 days)
HUGE DENTAL MATERIAL CO., LTD.
It is intended for use as a tooth in a denture.
These teeth are used for making full or partial dentures. The artificial resin teeth are mounted on an appliance made of dental acrylic resin. The appliance is made to fit the patient's mouth and is a removable. It is not implanted.
The Synthetic Polymer Teeth (Kaifeng/Crystal, Kaili, Kaijing, Kaiyue, MAIST and Kaitong/Royal) used in the production of dentures are produced through a dough molding process. Polymethylmethacrylate (PMMA) is mixed with methylmethacrylate monomer and a crosslinking agent.
Once the polymerization process has been carried out, the teeth are obtained and the next step is to remove any burrs and polish them.
The provided text describes a 510(k) premarket notification for "SYNTHETIC POLYMER TEETH". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through clinical studies.
Therefore, the document explicitly states:
- "Discussion of Clinical Tests Performed: None"
This means there was no clinical study conducted to establish performance and acceptance criteria for the device itself. Instead, the submission relies on the established safety and effectiveness of the predicate devices and the new device's material and manufacturing similarity to them.
As a result, I cannot provide the requested information in the format of acceptance criteria and reported device performance based on a study, as such a study was not performed as part of this 510(k) submission.
To answer your request based on the provided document, here's what can be extracted:
No Clinical Study Performed for this Device
The submission explicitly states that no clinical tests were performed to establish performance or meet specific acceptance criteria for the SYNTHETIC POLYMER TEETH.
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. No acceptance criteria were defined or measured through a clinical study for this device as part of the 510(k) submission. The submission relies on establishing substantial equivalence to predicate devices through non-clinical bench and biocompatibility testing.
2. Sample size used for the test set and the data provenance
Not applicable. No clinical test set was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No clinical test set and thus no ground truth established by experts for a test set.
4. Adjudication method for the test set
Not applicable. No clinical test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a preformed plastic denture tooth, not an AI-powered diagnostic or assistive technology. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a preformed plastic denture tooth, not an algorithm.
7. The type of ground truth used
Not applicable. No clinical study was performed requiring ground truth.
8. The sample size for the training set
Not applicable. No machine learning model was developed for this device.
9. How the ground truth for the training set was established
Not applicable. No machine learning model was developed for this device.
Ask a specific question about this device
Page 1 of 1